Kraj: Hiszpania
Język: angielski
Źródło: HMA (Heads of Medicines Agencies)
lawsonia intracellularis 79433 IU
Boehringer Ingelheim Vetmedica GmbH
QI09AE
Oral lyophilisate
Live bacterial vaccines
Pigs Food
2012-05-01
Page 1 of 6 _ _ SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 6 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enterisol Ileitis lyophilisate and diluent for oral suspension for pigs Enterisol Ileitis vet. (DK, NO, SV) lyophilisate and diluent for oral suspension for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Attenuated live bacteria _Lawsonia intracellularis_ (MS B3903). One 2 ml dose of reconstituted vaccine contains: ACTIVE SUBSTANCE: _Lawsonia intracellularis_: At least: 1 x 10 4.9 TCID 50 * _ _ _ _ Maximum: 1 x 10 6.1 TCID 50 * *: Tissue Culture Infective Dose DILUENT: Sterile water for oral administration: q.s. ad 2.0 ml For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and diluent for oral suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (weaned pigs from 3 weeks of age). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs from 3 weeks of age and older to reduce the intestinal lesions caused by _Lawsonia intracellularis_ infection and to reduce growth variability and loss of weight gain associated with the disease. Under field conditions, the difference in average daily weight gain was seen to be up to 30 g/day when vaccinated pigs were compared to unvaccinated pigs. Onset of protection occurs as early as 3 weeks post vaccination and lasts for at least 17 weeks. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS The vaccine has not been tested in breeding boars, therefore do not vaccinate breeding boars. Page 3 of 6 Do not vaccinate animals which are receivin Przeczytaj cały dokument